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QUOTED. Feb. 4, 2019. Brian Ludovico.

Executive Summary

Companies shouldn't be nervous about taking part in the Medical Device Single Audit Program if they already follow the international quality systems standard ISO 13485. That's the message here from NSF International's Brian Ludovico.

Some manufacturers "become nervous about an MDSAP audit – 'Oh my gosh, my gosh, my gosh, MDSAP, oh my gosh … I've got to get ready for this, I've got to get ready for this.' But be confident in yourself that you're already ready for it. You've been doing this all along." – Brian Ludovico, executive director, MDSAP regulatory certification, NSF International


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